BEUDAMED
    FDA Recall Terminated

    Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l,

    Recall: Z-2152-2008 · Initiated May 8, 2008

    Recall

    Recall Number
    Z-2152-2008
    Event Number
    48435
    Firm
    Opti Medical Systems Inc
    FEI Number
    3004102403
    Product Code
    GIO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 8, 2008
    Posted
    August 14, 2008
    Terminated
    January 22, 2010
    Address
    235 Hembree Park Dr, Ste 200, Roswell, GA, 300765700

    Description

    Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l,

    Reason

    This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.

    Action

    Opti Medical sent a Recall Notice, dated May 8, 2008 to all consignees. Consignees were notified via email on/about May 5th thru 7th , 2008. They were instructed to discontinue use of the affected lot and to immediately return all remaining product to OPTI Medical for replacement.

    Distribution

    Worldwide Distribution: USA, Puerto Rico, Austria, China, Chile, Cyprus, Great Britain, Japan, Netherlands, and Senegal

    Quantity

    31750 tubes